The Quality Control Specialist serves as a technical subject matter expert for Quality Control processes within the manufacturing site. This position provides technical guidance, supports laboratory operations, and ensures compliance with established quality standards, internal procedures, and applicable regulatory requirements.
Key Responsibilities
- Lead and oversee the daily activities of two Quality Control Technicians.
- Provide technical guidance and expertise on Quality Control processes, testing methods, and laboratory best practices.
- Support the implementation, validation, and continuous improvement of testing techniques and analytical methodologies.
- Collaborate with cross-functional teams to develop, revise, and maintain Quality Control Standard Operating Procedures (SOPs).
- Perform and support laboratory testing activities, including the handling and testing of biological samples when required.
- Conduct inspections, testing, and release activities for raw materials, components, work-in-process, and finished products according to established specifications.
- Ensure accurate documentation of testing results, quality records, and compliance with document control requirements.
- Participate in investigations of non-conformances, root cause analyses, and implementation of corrective and preventive actions.
- Support internal and external audits related to Quality Control processes and Quality Management System requirements.
- Ensure compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
- Promote continuous improvement initiatives to enhance laboratory efficiency, product quality, and regulatory compliance.
Required QualificationsEducation
- Bachelor's degree in Life Sciences, Chemistry, Biochemistry, or a related scientific discipline.
Experience
- Minimum of 3 years of experience in Quality Control laboratories, analytical testing, or laboratory environments.
- Proven experience working under GLP and GMP requirements.
- Experience in regulated industries such as Medical Devices, In Vitro Diagnostics (IVD), Pharmaceuticals, or similar environments is highly preferred.
- Ability and willingness to handle blood samples and perform glucose-related or other biological testing procedures.
- Phlebotomy experience or certification is considered an asset.
Knowledge, Skills, and Competencies
- Strong understanding of Quality Control systems, laboratory operations, and testing methodologies.
- Ability to interpret technical specifications, quality requirements, and testing procedures.
- Knowledge of sampling techniques, document control practices, and root cause investigation methodologies.
- Excellent verbal and written communication skills.
- Proficiency in Microsoft Office and quality documentation systems.
- Strong organizational skills, attention to detail, and ability to maintain accurate records.
- Ability to lead technical activities, provide guidance to team members, and drive process improvements.
Language Requirements
- Advanced English preferred; strong intermediate English required at a minimum.
- Ability to effectively communicate technical and operational information in both verbal and written formats.
- Comfortable participating in meetings, delivering presentations, and collaborating with international teams in English.
- Bilingual English/Spanish skills are highly desirable.
Lugar de trabajo: Empleo presencial
